Principal Regulatory Affairs Specialist

Getinge; Lansing (MI); Remote; USD 116,000 - 148,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs professional to oversee compliance for innovative medical devices. This role involves developing regulatory strategies, leading product development projects, and ensuring adherence to FDA and ISO standards. Join a dynamic team dedicated to improving healthcare access and outcomes. With a commitment to innovation and quality, this position offers an exciting opportunity to make a meaningful impact in the medical field. If you are passionate about regulatory affairs and want to contribute to life-saving technologies, this role is perfect for you.

Benefits

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Assistance Resources

Life Insurance

Short and Long Term Disability Benefits

Health and Dependent Care Flexible Spending Accounts

Parental and Caregiver Leave

Tuition Reimbursement

Qualifications

• 8+ years of experience in Regulatory Affairs in a medical device environment.
• Proficient in FDA regulations and ISO standards.

Responsibilities

• Lead compliance activities and prepare regulatory strategies for new devices.
• Negotiate with regulatory entities and maintain quality management systems.

Skills

Regulatory Affairs

Analytical Skills

Negotiation Skills

Project Management

Communication Skills

Education

Bachelor's Degree

Tools

MS Office (Word/Excel)

Job description

Remote Work: 3-5 days

Salary Range: $116,640 to 148,000 + 15% STIP

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Healthmark, A Getinge company was founded in 1969 and employs over 300 people and is a growing company. We strive to provide customers with quality products and support services in a timely and effective manner.

Full Time

Monday - Friday

Job Overview

Responsible for internal, domestic and international compliance activities. Prepare comprehensive regulatory strategies for new devices and post market changes. Clearly communicates strategies to RA management, project teams and business unit leadership. Preparing regulatory filings for new products, as well as post market changes. As necessary, reviews complex regulatory issues with RA management.

Job Responsibilities and Essential Duties

• Lead business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art requirements are maintained.
• Able to identify risks within regulatory strategies, project plan and outline proposal for balancing the project risks to projects teams and RA management.
• Build relationships and participates as a member of a cross-functional product development team.
• Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management.
• Drive improvement in regulatory aspects of the Quality management system, and in developing processes and documenting procedures to ensure an effective Quality system is maintained.
• Prepares Regulatory strategy/plans and requirements by collaborating and partnering with clinical, medical, R&D, marketing, and quality to ensure a consistent regulatory approach to global regulators.
• Prepares worldwide regulatory submissions/registrations including collecting information and documentation for submissions to regulatory agencies.
• Ensures compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect.
• Participates in the review and disposition of labeling, promotional material, and product modifications.
• Prepares documentation and coordinates activities related to EU MDR, PMA amendments, PMA supplements, PMA annual reports, Q-subs, 510(k)s, IDEs, technical documentation and assure timely regulatory clearances/approvals.
• Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations, the MDD, EuMDR, CMDR, and other international regulations.
• Participates in cross-functional departmental tea projects and products development activities/meetings.
• Creatively identify risk-based solutions and strategies for problem solving.
• Support with Field Correction and Recall activities.
• Responsible for FDA/ISO/MDD/MDR/CMDR compliance documentation.
• Participates in and support internal and third-party audits.
• Mentor and coach Getinge regulatory professionals in their development.
• Assists in special projects as needed.
• Contributes to team effort by accomplishing related duties.

Minimum Requirements

• Bachelor’s Degree and a minimum eight years of directly related experience in Regulatory Affairs in a medical device environment, or a minimum twelve years of directly related experience in Regulatory Affairs in a medical device environment.
• Experience with the preparation, submissions and approval for medical devices is required including 510(k) or PMA.
• Understands the requirements of FDA 21CFR Part 820, EU MDD, EU MDR, MDSAP, CMDR and ISO 13485.
• Proficient computer skills, including MS office applications (Word/Excel) are required.

Required Knowledge, Skills and Abilities

• Ability to multi-task, handling several projects simultaneously, in a fast-paced environment.
• Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills.
• Demonstrated proficiency in regulatory planning and strategy submissions along with strong negotiation skills.
• Ability to represent Regulatory Affairs to other departments.
• Working knowledge of principle compliance focused ISO Standards (13485, 14971, 62366) and the use of ISO Standards as special controls.
• RCA certification preferred.

Supervision/Management Of Others: None

Internal and External Contacts / Relationships:

• Maintains effective relationships with internal customers.
• Build relationships and participates as a member of a cross-functional product development team.
• Professionally negotiate/communicate directly with regulatory entities (e.g., governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level.

Environmental/Safety/Physical Work Conditions:

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• May work extended hours during peak business cycles.

At Healthmark a Getinge company, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off.
• Wellness initiative & Health Assistance Resources.
• Life Insurance.
• Short and Long Term Disability Benefits.
• Health and Dependent Care Flexible Spending Accounts.
• Parental and Caregiver Leave.
• Tuition Reimbursement.

Healthmark a Getinge company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

The base salary for this position is a minimum of $116,640 to 148,000 + 15% STIP.

Travel 10-15%

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.